Progrip Versus ProFlor: Two Fixation Free Devices for Laparoscopic Inguinal Hernia Repair (ProPro)

University of Palermo

Status and phase: Invitation-only; Phase 4

Conditions: Laparoscopic Surgery; Hernia, Inguinal

Treatments: Procedure: Progrip group; Procedure: Proflor group

Study type: Interventional

Funder types: Other

Identifiers

NCT06556498

ProPro study

Details and patient eligibility

About

there are currently two methods for fixation free laparoscopic inguinal hernia repair specifically based on the intrinsic properties of the device used. The Progrip mesh technique leaves the hernia orifice patent and relies on the established principle of strengthening the groin through scar tissue incorporation induced by foreign body reaction. In contrast, the ProFlor concept introduces a 3D dynamic regenerative scaffold that permanently obliterates the defect and regenerates the herniated inguinal barrier. This report presents the outcomes of laparoscopic techniques employing Progrip and ProFlor in randomized clinical trial. The results of this clinical study may have the potential to pave the way for innovative advancements in hernia repair techniques.

Enrollment: 150 estimated patients

Sex: Male

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• bilateral inguinal hernia

Exclusion criteria

• Recurrent inguinal hernia
• Incarcerated inguinal hernia
• Hernia not in the inguinal area
• Signs of obvious local or systemic infection
• ASA score > 4
• Presenting with unstable angina or NYHA class of IV
• Pregnant
• Active drug user
• Immunosuppression, chemotherapy
• Chronic renal insufficiency
• Abdominal ascites
• Infection in area of the surgical field
• BMI >34

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

ProFlor group

Active Comparator group

Description:

patients underwent to laparoscopic hernia repair with the use of ProFlor mesh

Treatment:

Procedure: Proflor group

Progrip group

Active Comparator group

Description:

patients underwent to laparoscopic hernia repair with the use of Progrip mesh

Treatment:

Procedure: Progrip group